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Bacterial Endotoxin Test and Wako
We contributed to the establishment of the bacterial endotoxin test method etc. from the dawn of the test and have supported the development and dissemination of bacterial endotoxin test as well as the development of measurement system etc. meeting the needs of present age.
| Bacterial Endotoxin test | Our LAL business | |
|---|---|---|
| 1950-1956 | Bang conducted the blood clotting study of horseshoe crabs. | |
| 1964 | Levin & Bang discovered the endotoxin to clot the blood corpuscles of horseshoe crabs. * 1 | |
| 1970 | Cooper, Levin, Wagner and others announced the possibility that LAL could be an alternative method to the rabbit pyrogen test (pyrogen test using rabbits). * 2 | |
| 1979 | Release of gel-clot technique reagents in Japan. | |
| 1980 | Gel-clot technique were listed in the USP (US Pharmacopoeia) as Bacterial Endotoxins Test (BET). | |
| 1985 | Release of Toxinometer | |
| 1987 | FDA issued Validation Guidelines for Limulus Test. | |
| 1988 |
Bacterial endotoxin test method (gel-clot technique) was listed in the Japanese Pharmacopoeia. (supplement 1 of the 11th edition) |
|
| 1993 | The international harmonization work on bacterial endotoxin test method was started. | |
| 1994 | Release of Limulus ES-II | |
| 1996 | In addition to the gel-clot technique, the turbidimetric technique and the chromogenic technique were listed in the Japanese Pharmacopoeia (the 13th edition). |
The first Bacterial Endotoxin Test Method Seminar was held. Release of Limulus Color KY. |
| 1999 | Each country's pharmacopoeia signed the harmonization agreement in BET international harmonization plan. | |
| 2000 | LAL business was started at Wako Chemicals USA Inc. | |
| 2010 |
Abolition of FDA Guideline for Limulus test. (Unified to USP BET) |
Release of Toxinometer ET-6000 |
| 2011 | FDA Guidance "Pyrogen and Endotoxins Testing: Q & A" was issued. |
Wako Chemicals USA Inc.,： Richmond plant acquired FDA approval. |
| 2012 | International harmonization agreement of bacterial endotoxin test method. | Release of PYROSTAR ES-F |
| 2013 |
BET International harmonization agreement Japan: March 21, 2013, Europe: May 2013, The United States: enforced on October 15, 2013. |
|
| 2015 | Release of Limulus ES-Ⅱplus CS |
【References】
＊1:Levin,J. and Bang,F.B. Bull. Johns Hopkins Hosp.,115,265 (1964)
＊2:Cooper JF, Levin J, Wagner HN. J Nucl Med 11,310 (1970)
